Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
研究概览
地位
条件
详细说明
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
55 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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-
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Copenhagen、丹麦、2100
- Rigshospitalet
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
• ≥18 years
- Male
- Signed informed consent
- Negative urine stix (erythrocytes, leucocytes and nitrite)
Exclusion Criteria:
- • Abnormalities, diseases or surgical procedures performed in the lower urinary tract
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Active comparator/Yellow catheter
SpeediCath coated catheter
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Speedicath, Intermittent catheterisation
其他名称：
|
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实验性的：NonCE marked intermittent catheter/red
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Paris, Intermittent catheterisation
其他名称：
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实验性的：NonCE marked intermittent catheter/green
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Paris, Intermittent catheter
其他名称：
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实验性的：NonCE marked intermittent catheter/Blue
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Paris, Intermittent catheter
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Discomfort during catheterisation measured by VAS-scale (0-10)
大体时间：10 measurements in an 11 week period. 10 min after each catheterisation
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A subject is assesing a VAS scale after each catheterisation.
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10 measurements in an 11 week period. 10 min after each catheterisation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety
大体时间：During the investigation 11 Weeks per subject
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Safety is evalueted continues while the subjects are testing the devices
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During the investigation 11 Weeks per subject
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Discomfort during urination post catheterisation
大体时间：10 measurements in an 11 week period. 10 min after each catheterisation
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Subjects own assesment.
Yes or no can be answered to discomfort during urination post catheterisation
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10 measurements in an 11 week period. 10 min after each catheterisation
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Haematuria
大体时间：10 measurements in an 11 week period. 10 min after each catheterisation
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Urine test after each catheterisation, and measured on a urine stix
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10 measurements in an 11 week period. 10 min after each catheterisation
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Handling during insertion, withdrawal
大体时间：10 measurements in an 11 week period. 10 min after each catheterisation
|
Ease of use assessed by nurses, measured on a 5 point scale
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10 measurements in an 11 week period. 10 min after each catheterisation
|
合作者和调查者
调查人员
- 研究主任：Susanne Gürtler, CTM、Coloplast A/S
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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